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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The OTC drug phenylephrine does not work to relieve congestion, an FDA advisory panel said Tuesday. The ingredient is found in a number of cold and allergy pills. FDA panel says common over-the ...
In September 2023, an FDA advisory committee of 16 experts held a two-day meeting, which culminated with the announcement that oral phenylephrine is not effective, and works no better than a ...
Actually, J&J came up with phenylephrine in the 70s, but nobody has bothered to use it until pseudoephedrine became restricted. From the link "In 1976, the FDA deemed a 10 milligram oral dose of phenylephrine safe and effective at relieving congestion, making it possible for companies to use the ingredient without conducting studies."
[9] [1] [10] [11] It was previously commonly used in prescription and over-the-counter cough and cold preparations. The medication is taken by mouth. [4] [12] Side effects of phenylpropanolamine include increased heart rate and blood pressure, among others. [13] [14] [15] [12] Rarely, phenylpropanolamine has been associated with hemorrhagic stroke.
The Food and Drug Administration (FDA) is proposing the removal from the market of a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work.
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence ...